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Dietary Supplement Safety and Regulation

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Updated June 04, 2014

Written or reviewed by a board-certified physician. See About.com's Medical Review Board.

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Always speak with your health care provider before taking any dietary supplements.

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Dietary supplements aren't regulated as strictly as medications. In the United States, for example, the Food and Drug Administration (FDA) doesn't require proof that dietary supplements are safe or effective before they are sold. Some products, like raspberry ketone, are advertised to have health benefits but have no clinical trials demonstrating safety or effectiveness. 

But supplement manufacturers must follow a few do's and don'ts when it comes to labeling and making certain claims on their products. The label on a dietary supplement bottle may state the supplement addresses a nutrient deficiency, supports health, or may have an effect on some function or structure of the body -- if these claims are supported by research. Each type of claim has a specific meaning:

  • A nutrient content claim states the approximate amount of the dietary substances in the product.
  • Health claims indicate a relationship between consuming the dietary substance and changing disease risk, if there is sufficient evidence. These claims are regulated by the FDA.
  • Structure or function claims describe how the dietary substances may affect the body. These claims are not regulated by the FDA, so it is up to each supplement manufacturer to be truthful and accurate with these claims.

Although dietary supplements don't have to prove safety or effectiveness before marketing, the FDA may determine that a dietary supplement is not safe. When that happens, the FDA can restrict or ban the sales of that product.

While dietary supplement use is considered to be generally safe, there are some things to think about if you're taking dietary supplements.

Always speak with your health care provider if you are:

  • Taking any medications, as some dietary supplements may have unwanted interactions.
  • Planning surgery, because some supplements can affect bleeding, or response to anesthesia.
  • Pregnant or nursing, since some supplements can affect the baby.
  • Thinking about taking a dietary supplement in place of medical treatment.

When it's time to choose your dietary supplements, you might be overwhelmed with all the brands and types available. Different products may be of different quality. Ask your health care provider, pharmacist, dietitian or nutritionist for suggestions about certain formulas or brands if you're not sure which ones to choose. Always follow the label instructions, unless your health care provider has advised you differently, because some supplements, such as vitamin B-6 and iron, can become toxic when taken in large amounts.

Sources:

NCCAM - National Institutes of Health. Using Dietary Supplements Wisely. http://nccam.nih.gov/health/supplements/wiseuse.htm Accessed November 12, 2009.

Office of Dietary Supplements. National Institutes of Health. Dietary Supplements: Background Information. http://ods.od.nih.gov/factsheets/dietarysupplements/. Accessed November 12, 2009.

United States Food & Drug Administration. Claims That Can Be Made for Conventional Foods and Dietary Supplements. http://www.fda.gov/Food/LabelingNutrition/LabelClaims/ucm111447.htm. Accessed November 12, 2009.

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